Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the life cycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to affect regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas.

Medicare Part D: challenges for dialysis patients. Part 1.

Dialysis patients require numerous medications and have high prescription drug costs compared with general Medicare patients, possibly making them more vulnerable to Medicare Part D policy-related issues. The purpose of this study was to identify problems that dialysis patients experience with Medicare Part D through a survey of dialysis social workers. The online survey was posted on www.kidneyhealthcarecoverage.org and results were collected from January 2010 through October 2010. It was completed by 184 social workers in 38 states, representing 14,200 patients. The greatest Part D plan restrictions were seen with the highest cost prescription medications--Lanthanum carbonate, sevelamer carbonate, and cinacalcet. Seventeen percent of social workers reported that dialysis patients were "very frequently" or "frequently" unaware of available Medicare Part D coverage and 54% reported that up to 20% of their patients continued to have no insurance coverage for prescription drugs. Social workers reported that patients affected by the coverage gap exhibited various changes in medication-taking behavior, such as skipping doses and decreasing dosing frequency. Higher out-of-pocket costs for some dialysis patients during the coverage gap led to reduced use of medications; such gaps in treatment could lead to increased use of medical services, but further data are needed. Currently, the government is slowly phasing out the coverage gap; this process should be completed by 2020. The anticipated shift of self-administered bone and mineral disorder medications from Part D into the dialysis bundle in 2014 has the potential to affect dialysis patients' access to these medications.

Usefulness of nutrition facts label for persons with chronic kidney disease.

OBJECTIVE: We sought to determine what information should be included on the nutrition facts label (NFL) to improve its usefulness for individuals with chronic kidney disease (CKD). DESIGN: Our survey asked for frequency of food-label reading, use of information on the label related to specific nutrients, and perceived needs. SETTING: Our survey was internet-based. SUBJECTS: Our subjects included 317 individuals with CKD and caregivers who self-subscribed to electronic mailing lists maintained by nationally based groups providing education and/or support for individuals with CKD. INTERVENTION: The intervention consisted of an analysis of survey results. MAIN OUTCOME MEASURES: Main outcome measures included respondent self-reported behaviors, opinions, attitudes, knowledge, and perceived needs related to the NFL in terms of foods and beverages. RESULTS: Survey respondents (81.8%) rated nutrition as important (39.2%) or very important (42.6%) when making food choices. A roughly equal number (82.6%) indicated reading the NFL often for the amounts of nutrients in a food. However, less than one fourth of the respondents (24.0%) were able to determine the amount of calcium in a food correctly, based on percent daily value (%DV), and many (64.6%) indicated they did not know how to convert the %DV to an absolute amount (the 100% daily value for calcium is 1000 mg). Respondents indicated that they decided not to purchase foods that did not list absolute amounts of nutrients of concern (58.4% for potassium, and 53.9% for phosphorus) on the NFL. CONCLUSIONS: Individuals with CKD would prefer, or find it more useful, to see nutrients of concern listed in absolute amounts on the NFL. They also indicated that potassium and phosphorus should be required on the label, to allow the option of determining whether to include a food in their diet.

State approaches to stem toll of chronic kidney disease.

Two dozen states have undertaken initiatives to address chronic kidney disease (CKD), with the goal of facilitating early identification of CKD and intervention to prevent the progression of CKD and its comorbidities. Each state has approached this goal in a different fashion. The impact of these varying initiatives should be evaluated so as to guide policy development in other jurisdictions.

TheUniform Anatomical Gift Act and organ donation in the United States.

The Uniform Anatomical Gift Act (UAGA) and its periodic revisions provide a template for the creation and amendment of legislation to adjust public policy and align it with developments in medical practice. It is also a model for statutory response to societal change as well as changes in regulatory and judicial precedents. Conversely, the history of the UAGA shows the limits of legislation to achieve certain social goals.

Chronic kidney disease: a public health problem that needs a public health action plan.

For a health problem or condition to be considered a public health issue, four criteria must be met: 1) the health condition must place a large burden on society, a burden that is getting larger despite existing control efforts; 2) the burden must be distributed unfairly (i.e., certain segments of the population are unequally affected); 3) there must be evidence that upstream preventive strategies could substantially reduce the burden of the condition; and 4) such preventive strategies are not yet in place. Chronic kidney disease meets these criteria for a public health issue. Therefore, as a complement to clinical approaches to controlling it, a broad and coordinated public health approach will be necessary to meet the burgeoning health, economic, and societal challenges of chronic kidney disease.

Medicare medical nutrition therapy: legislative process and product.

The new Medicare benefit, medical nutrition therapy (MNT), came into effect January 2002-the product of a lengthy legislative process. Over several years, evidence-based advocacy by groups such as the American Diabetic Association and the National Kidney Foundation led to a legislative product that was introduced and passed by Congress. More recently, the legislation entered an implementation process, including the most recent Coverage Determination phase. The definition of MNT and the scientific evidence supporting it are presented. Evidence-based nutrition now enters a new phase of implementation and additional analysis.